GAMMAPLEX® 10%

FDA INDICATION: Primary immunodeficiency disease (PIDD) and idiopathic thrombocytopenic purpura (ITP) Package Insert

FORM: Liquid

DISTRIBUTOR: Bio Products Laboratory

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 4.9–5.2

CONCENTRATION: 10%

IGA CONTENT: <20 μg/mL

% IGG: ≥98%

NA CONTENT: <30 mmol/100mL NaCl

DILUENT: N/A

OSMOLALITY (MOSM/L): ≥240 mOsmol/kg (typically 280)

MAX INFUSION RATE: 0.08 mL/kg/min

SUGAR CONTENT: No added sugars

SHELF LIFE: 36 months

STORAGE REQUIREMENTS: Store at room temperature at 2–25°C (36–77°F). Do not freeze. Protect from light.

OTHER WEBSITES: gammaplex.com